The present is a multicenter, observational study organized by the Prostatic Obstruction Investigation Team (POInT), with a main purpose of looking into the current status and symptom progression of male lower urinary tract symptoms patients in China.
Lower urinary tract symptoms (LUTS) is a common medical condition negatively affecting people's quality of life worldwide. LUTS may be caused by structural or functional abnormalities in 1 or more parts of the lower urinary tract, including bladder, prostate, internal and external urethral sphincter and distal urethra. Furthermore, evidence exists to demonstrate that LUTS is associate with lifestyle factors, systemic comorbidities and geriatric diseases, such as smoking, obesity, metabolic syndrome, chronic kidney diseases and chronic obstructive pulmonary disease etc. So far, there is lack of evidence to illustrate the symptom features and comorbidities among Chinese male LUTS patients. Therefore, this multicenter clinical study aims to investigate the present status and symptom progression among male LUTS patients in China.
Study Type
OBSERVATIONAL
Enrollment
11,500
Patients in this group will receive oral medication(s) depending on doctors' prescriptions.
Patients in this group will receive surgical treatment.
Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe changes of IPSS scores between baseline and follow-up
Measured using standard IPSS scoring system
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery.
The changes of nocturia symptoms between baseline and follow-up
Measured using standard ICIQ-N-QoL score
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery
The changes of erectile function between baseline and follow-up
Measured using standard IIEF score
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery
The changes of maximum flow rate (ml/s) between baseline and follow-up
Maximum flow rate will be measured using urinary flow study
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery
The changes of post void residual volume (ml) between baseline and follow-up
post void residual volume (ml) will be measured using urinary flow study
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery
The changes of detrusor pressure at maximum flow rate (cmH2O) between baseline and follow-up
It will be measured using pressure-flow study
Time frame: Measured at baseline (if surgical treatment is required) and 1, 6, 18, 24 months after surgery
The changes of prostate volume (ml) between baseline and follow-up
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Prostate volume (ml) will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) = length (mm) \* width (mm) \* height (mm) \* 0.52
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment
The changes of intravesical prostate protrusion (mm) between baseline and follow-up
Intravesical prostate protrusion (mm) will be measured using transrectal prostate ultrasound and calculated as the distance between the tip of the prostate median lobe and bladder neck
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment
The changes of Blood pressure between baseline and follow-up
systolic pressure/ diastolic pressure in mmHg.
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
The changes of Blood lipid between baseline and follow-up
The blood lipid level will be assessed using multiple serum parameters, namely, cholesterol (mmol/L), triglyceride (mmol/L), high-density lipoprotein (mmol/L), low-density lipoprotein (mmol/L), lipoprotein-a (mmol/L)
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
The changes of Blood glucose between baseline and follow-up
The blood glucose level will be assessed using multiple serum parameters, namely, fast blood-glucose (mmol/L), glycosylated hemoglobin (%), glycated albumin (%)
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
The changes of Kidney function between baseline and follow-up
The kidney function will be assessed using multiple serum and urine parameters, namely, serum creatinine (μmoI/L), cystatin-C (mg/L), eGRF (calculated via both CKD-EPI equation and MDRD equation), BUN (mmol/L), uric acid (μmoI/L), β2-MG (mg/L), NAG (U/L), Na (mmol/L), K (mmol/L), the degree of urine protein
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
The changes of PSA (ng/ml) between baseline and follow-up
Serum PSA level will be measured to rule out prostate cancer
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
The changes of RBC (/HP) between baseline and follow-up
Urine RBC will be measured to detect the incidence of urinary tract infection or tumor
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
The changes of WBC (/HP) between baseline and follow-up
Urine WBC will be measured to detect the incidence of urinary tract infection
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.